MEKTOVI Drug Patent Profile
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Which patents cover Mektovi, and what generic alternatives are available?
Mektovi is a drug marketed by Array Biopharma Inc and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.
This drug has two hundred and thirty-one patent family members in fifty-five countries.
The generic ingredient in MEKTOVI is binimetinib. One supplier is listed for this compound. Additional details are available on the binimetinib profile page.
DrugPatentWatch® Generic Entry Outlook for Mektovi
Mektovi was eligible for patent challenges on June 27, 2022.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be October 18, 2033. This may change due to patent challenges or generic licensing.
There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There is one tentative approval for the generic drug (binimetinib), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
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Summary for MEKTOVI
| International Patents: | 231 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 92 |
| Clinical Trials: | 35 |
| Patent Applications: | 1,184 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for MEKTOVI |
| What excipients (inactive ingredients) are in MEKTOVI? | MEKTOVI excipients list |
| DailyMed Link: | MEKTOVI at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for MEKTOVI
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for MEKTOVI
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Pfizer | Phase 2 |
| Merck Sharpe & Dohme LLC | Phase 2 |
| Cancer Research UK | Phase 3 |
Paragraph IV (Patent) Challenges for MEKTOVI
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| MEKTOVI | Tablets | binimetinib | 15 mg | 210498 | 3 | 2022-06-27 |
US Patents and Regulatory Information for MEKTOVI
MEKTOVI is protected by nine US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of MEKTOVI is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting MEKTOVI
Compounds and compositions as protein kinase inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: INDICATED IN COMBINATION WITH ENCORAFENIB FOR THE TREATMENT OF MELANOMA
Compounds and compositions as protein kinase inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MEKTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH ENCORAFENIB, FOR THE TREATMENT OF PATIENTS WITH METASTATIC NON SMALL CELL LUNG CANCER WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST
N3 alkylated benzimidazole derivatives as MEK inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Compounds and compositions as protein kinase inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: INDICATED IN COMBINATION WITH ENCORAFENIB FOR THE TREATMENT OF MELANOMA MEDIATED BY A B-RAF PROTEIN KINASE
Compounds and compositions as protein kinase inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: MEKTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH ENCORAFENIB, FOR THE TREATMENT OF PATIENTS WITH METASTATIC NON SMALL CELL LUNG CANCER WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST
Preparation of and formulation comprising a MEK inhibitor
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Preparation of and formulation comprising a MEK inhibitor
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING MELANOMA
Compounds and compositions as protein kinase inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: INDICATED IN COMBINATION WITH ENCORAFENIB FOR THE TREATMENT OF MELANOMA WITH A BRAF MUTATION
Preparation of and formulation comprising a MEK inhibitor
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF MELANOMA WITH A BRAF MUTATION
FDA Regulatory Exclusivity protecting MEKTOVI
ENCORAFENIB IS INDICATED IN COMBINATION WITH BINIMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH A BRAF V600E OR V600K MUTATION, AS DETECTED BY AN FDA-APPROVED TEST
Exclusivity Expiration: ⤷ Sign Up
ENCORAFENIB IN COMBINATION WITH BINIMETINIB, IS INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Array Biopharma Inc | MEKTOVI | binimetinib | TABLET;ORAL | 210498-001 | Jun 27, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Array Biopharma Inc | MEKTOVI | binimetinib | TABLET;ORAL | 210498-001 | Jun 27, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Array Biopharma Inc | MEKTOVI | binimetinib | TABLET;ORAL | 210498-001 | Jun 27, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Array Biopharma Inc | MEKTOVI | binimetinib | TABLET;ORAL | 210498-001 | Jun 27, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for MEKTOVI
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Array Biopharma Inc | MEKTOVI | binimetinib | TABLET;ORAL | 210498-001 | Jun 27, 2018 | ⤷ Sign Up | ⤷ Sign Up |
| Array Biopharma Inc | MEKTOVI | binimetinib | TABLET;ORAL | 210498-001 | Jun 27, 2018 | ⤷ Sign Up | ⤷ Sign Up |
| Array Biopharma Inc | MEKTOVI | binimetinib | TABLET;ORAL | 210498-001 | Jun 27, 2018 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for MEKTOVI
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Pierre Fabre Medicament | Mektovi | binimetinib | EMEA/H/C/004579 Binimetinib in combination with encorafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. |
Authorised | no | no | no | 2018-09-20 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for MEKTOVI
When does loss-of-exclusivity occur for MEKTOVI?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 9630
Patent: PREPARACIÓN DE UN INHIBIDOR DE MEK Y FORMULACIÓN QUE LO COMPRENDE
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2015008623
Patent: preparação e formulação compreendendo um inibidor de mek
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 88474
Patent: PREPARATION D'UN INHIBITEUR DE MEK ET FORMULATION LE CONTENANT (PREPARATION OF AND FORMULATION COMPRISING A MEK INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Patent: 79071
Patent: PREPARATION DE DERIVE BENZIMIDAZOLE CRISTALLISE COMME INHIBITEUR MEK ET FORMULATION LA COMPRENANT (PREPARATION OF CRYSTALLIZED BENZIMIDAZOLE DERIVATIVE AS MEK INHIBITOR AND FORMULATION COMPRISING SAME)
Estimated Expiration: ⤷ Sign Up
China
Patent: 4870427
Patent: Preparation of and formulation comprising a mek inhibitor
Estimated Expiration: ⤷ Sign Up
Patent: 9336824
Patent: MEK抑制剂的制备和包含MEK抑制剂的制剂 (PREPARATION OF AND FORMULATION COMPRISING A MEK INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Patent: 9456272
Patent: MEK抑制剂的制备和包含MEK抑制剂的制剂 (PREPARATION OF AND FORMULATION COMPRISING A MEK INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 22670
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 09182
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 09182
Patent: PRÉPARATION D'UN INHIBITEUR DE MEK ET FORMULATION LE CONTENANT (PREPARATION OF AND FORMULATION COMPRISING A MEK INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Patent: 02351
Patent: PRÉPARATION D'UN INHIBITEUR DE MEK ET FORMULATION LE CONTENANT (FORMULATION COMPRISING A MEK INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 14254
Patent: 抑制劑的製備和包含 抑制劑的製劑 (PREPARATION OF AND FORMULATION COMPRISING A MEK INHIBITOR MEK MEK)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 47708
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 85939
Estimated Expiration: ⤷ Sign Up
Patent: 37838
Estimated Expiration: ⤷ Sign Up
Patent: 16503391
Patent: ＭＥＫ阻害剤の調製およびＭＥＫ阻害剤を含む製剤
Estimated Expiration: ⤷ Sign Up
Patent: 18135399
Patent: ＭＥＫ阻害剤の調製およびＭＥＫ阻害剤を含む製剤 (PREPARATION OF MEK INHIBITOR AND FORMULATION COMPRISING MEK INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Patent: 19194272
Patent: ＭＥＫ阻害剤の調製およびＭＥＫ阻害剤を含む製剤 (PREPARATION OF MEK INHIBITOR AND FORMULATION COMPRISING MEK INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Jordan
Patent: 0130304
Patent: مستحضر وصيغة تشتمل على مثبط MEK (PREPARATION OF AND FORMULATON COMPRISING A MEK INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 09182
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 09182
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 69391
Patent: ПОЛУЧЕНИЕ И СОСТАВЛЕНИЕ КОМПОЗИЦИИ, СОДЕРЖАЩЕЙ ИНГИБИТОР МЕК (PREPARATION OF AND FORMULATION COMPRISING A MEK INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Patent: 15118572
Patent: ПОЛУЧЕНИЕ И СОСТАВЛЕНИЕ КОМПОЗИЦИИ, СОДЕРЖАЩЕЙ ИНГИБИТОР МЕК
Estimated Expiration: ⤷ Sign Up
Patent: 18127873
Patent: ПОЛУЧЕНИЕ И СОСТАВЛЕНИЕ КОМПОЗИЦИИ, СОДЕРЖАЩЕЙ ИНГИБИТОР MEK
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 09182
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 72498
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 50316
Estimated Expiration: ⤷ Sign Up
Patent: 1427956
Patent: Preparation of and formulaton comprising a MEK inhibitor
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering MEKTOVI around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Chile | 2012002380 | Compuestos derivados de bezoimidazol, inhibidores de mek; utiles en el tratamiento del cancer.(divisional solicitud cl 521-03) | ⤷ Sign Up |
| Luxembourg | C00101 | ⤷ Sign Up | |
| Iceland | 8959 | N3 alkýleraðar bensimíðasól afleiður sem MEK hindrar | ⤷ Sign Up |
| Canada | 2537098 | DERIVES DE BENZIMIDAZOLE N3 ALKYLES UTILISES COMME INHIBITEURS DE MEK (N3 ALKYLATED BENZIMIDAZOLE DERIVATIVES AS MEK INHIBITORS) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MEKTOVI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2470526 | SPC/GB19/009 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: ENCORAFENIB OR PHARMACEUTICALLY ACCEPTABLE SALTS OR SOLVATES THEREOF; REGISTERED: UK EU/1/18/1314/001-002 20180924; UK PLGB 00603/0240-0001 20180924; UK PLGB 00603/0241-0001 20180924 |
| 2470526 | 2019012 | Norway | ⤷ Sign Up | PRODUCT NAME: ENKORAFENIB ELLER ET FARMASOEYTISK AKSEPTABELT SALT ELLER SOLVAT DERAV; REG. NO/DATE: EU/1/18/1314 20180925 |
| 1482932 | 122019000022 | Germany | ⤷ Sign Up | PRODUCT NAME: BINIMETINIB EINSCHLIESSLICH BINIMETINIB IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES ODER SOLVATS; REGISTRATION NO/DATE: EU/1/18/1315 20180920 |
| 1482932 | 14/2019 | Austria | ⤷ Sign Up | PRODUCT NAME: BINIMETINIB UND PHARMAZEUTISCH ANNEHMBAREN SALZE ODER SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/18/1315 (MITTEILUNG) 20180924 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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